Useful preparations of water-insoluble or poorly soluble substances are needed in the pharmaceutical industry. Particularly desired are formulations of water-insoluble or poorly soluble drugs that are stable when dispersed in water, in lyophilized form, or when spray-dried.
Current technology for administering formulations of insoluble drugs, described in, for example, U.S. Pat. Nos. 5,091,188; 5,091,187 and 4,725,442, is directed to either (a) coating small drug particles with natural or synthetic phospholipids or (b) dissolving the drug in a suitable lipophilic carrier and forming an emulsion stabilized with natural or semisynthetic phospholipids. One of the disadvantages of these formulations is that certain drug particles in suspension tend to grow over time because of the dissolution and reprecipitation phenomenon known as “Ostwald ripening.” See, e.g., Luckham, Pestic. Sci., (1999) 25, 25-34.
For these and other reasons, there remains a need for improved and alternative formulations of water-insoluble and poorly soluble substances. The invention provides such compositions and methods of producing and using the same. These and other advantages of the invention, as well as additional inventive features, will be apparent from the description of the invention provided herein.